Streamline Change Control and Variation Management

This video provides an in-depth exploration of streamlining change control and variation management within the biopharmaceutical industry, focusing on how Veeva's unified Quality and Regulatory Information Management (RIM) solutions address long-standing challenges. The presentation, led by Veeva's Quality and Regulatory strategy teams, highlights the complexities of managing product changes that often have significant regulatory impact. It emphasizes that traditional, manual, and siloed approaches lead to inefficiencies, compliance risks, and delayed product availability, setting the stage for Veeva's integrated platform as a transformative solution.

The core of the discussion revolves around Veeva's vision to build an "industry cloud for Life Sciences," offering best-of-breed applications designed with industry best practices and compliance in mind. The speakers detail the functionalities of Veeva's Vault Quality Suite (including Quality Docs, Station Manager, Training, and QMS) and the Vault RIM Suite (Registrations, Submissions, Submissions Publishing, and Submissions Archive). A key message is that while these are presented as separate applications for licensing, they are built on a single Vault platform and data model, enabling seamless data flow and process unification, particularly for complex processes like change control.

The video then delves into a specific workflow demonstrating how a change request initiated in Vault QMS triggers a regulatory impact assessment within Vault Registrations. This bi-directional integration allows quality teams to quickly understand the regulatory implications (impacted licenses, local market requirements) and regulatory teams to update filing statuses, which are then visible in real-time within QMS. This automation significantly reduces manual effort, improves compliance, optimizes costs, and enables more informed product shipment decisions, ultimately preventing potential short supply situations for critical medicines. The Q&A session further clarifies technical aspects, integration capabilities (e.g., with ERP systems), and Veeva's roadmap for regulatory standards like IDMP.

Key Takeaways:

• Complexity of Change Control: Change control in biopharma is a highly complex, multi-step process that can take anywhere from six months to two years to complete. Large organizations may evaluate tens of thousands of change requests and approve upwards of 15,000 changes annually, many with significant downstream regulatory impact.
• Challenges of Legacy Systems: Traditional approaches rely on separate, siloed quality and regulatory systems, leading to manual "swivel-chair" processes, data duplication, and a lack of real-time visibility. Regulatory impact assessments, often managed via spreadsheets, are cumbersome and prone to errors, hindering compliance and extending cycle times.
• Veeva's Unified Platform Approach: Veeva aims to provide an "industry cloud for Life Sciences" with best-of-breed applications (Vault Quality and Vault RIM suites) built on a single, multi-tenant cloud platform. This unified approach manages content, data, and business processes seamlessly, ensuring consistency and compliance.
• Vault Quality Suite Components: The suite includes Vault Quality Docs for GxP document management, Vault Station Manager for shop floor access, Vault Training for managing training matrices, and Vault QMS for structured data management of quality events like deviations, CAPA, audits, risk management, and change control.
• Vault RIM Suite Components: Designed to overcome regulatory fragmentation, the RIM suite comprises Vault Registrations (for tracking, regulatory impact assessments, xEVMPD/IDMP), Vault Submissions (for content planning, authoring), Vault Submissions Publishing, and Vault Submissions Archive, all leveraging a single data model for end-to-end visibility.
• Streamlined QMS-RIM Integration: A key benefit is the automated, bi-directional integration between Vault QMS and Vault Registrations. This allows for the seamless exchange of information regarding change controls and their regulatory impact, eliminating manual handoffs and reducing errors.
• Automated Regulatory Impact Assessment: When a change request is created in QMS, the system can automatically trigger a regulatory impact assessment in Registrations. This identifies impacted licenses and local market requirements, feeding this critical information back to QMS to inform decisions on whether to proceed with the change.
• Real-time Regulatory Status Visibility: As regulatory filings progress and approvals are received from health authorities, their status is automatically updated and made visible within QMS. This real-time information is crucial for making accurate and timely product shipment decisions.
• Significant Business Benefits: Unifying change control across quality and regulatory leads to greater compliance, cost optimization through reduced manual effort and faster cycle times, and improved decision-making for product shipments, ultimately preventing critical medicine shortages.
• IDMP Implementation Strategy: Veeva currently supports xEVMPD and is committed to incrementally building out IDMP functionality. The strategy involves developing features as the EMA releases clearer implementation guide details, leveraging Veeva's three-release-per-year cycle.
• GxP System Change Management: Vault QMS fully supports managing change requests specifically related to GxP systems, offering flexibility to configure multiple types of changes within the change control workflow process.
• Productized Connector: The integration between Vault QMS and Vault Registrations is a productized connector, not custom code. It is included with active subscriptions to both modules and requires configuration, such as mapping products and lifecycle states between the two systems.
• ERP Integration Capabilities: Vault QMS can integrate with ERP systems for various purposes, including placing impacted batches on hold or importing master data, ensuring data consistency and streamlined processes across the enterprise landscape.
• Flexible Change Plan Definition: While the delivered application suggests a high-level change plan for initial impact assessment, the workflow within Vault QMS can be configured to align with an organization's preference for defining a full change management plan before initiating impact assessments.

Tools/Resources Mentioned:

• Veeva Vault Quality Suite (Vault Quality Docs, Vault Station Manager, Vault Training, Vault QMS)
• Veeva Vault RIM Suite (Vault Registrations, Vault Submissions, Vault Submissions Publishing, Vault Submissions Archive)
• EMA Gateway
• ERP systems (as potential integration points)
• Excel spreadsheets, Microsoft Project (mentioned as legacy tools for content plans)

Key Concepts:

• Change Control: A formal, documented process to manage and track all changes made to a product, system, or process, ensuring they are introduced in a controlled and coordinated manner.
• Variation Management: The process of managing changes to approved regulatory submissions for medicinal products, often requiring communication and approval from health authorities.
• Unified Quality and Regulatory Information Management (RIM): An integrated approach that combines quality management systems (QMS) with regulatory information management systems to create a seamless flow of data and processes, enhancing efficiency and compliance.
• Regulatory Impact Assessment: The critical step of evaluating how a proposed change will affect existing regulatory approvals, licenses, and submission requirements in various markets.
• Local Disposition: The determination of specific regulatory actions or filings required in individual local markets based on the outcome of a regulatory impact assessment.
• GxP: A comprehensive set of guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) that ensure the quality, safety, and integrity of products and processes in the life sciences industry.
• 21 CFR Part 11: A regulation from the U.S. Food and Drug Administration (FDA) that sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• xEVMPD (extended EudraVigilance Medicinal Product Dictionary): A European standard for the electronic submission of medicinal product data to the European Medicines Agency (EMA).
• IDMP (Identification of Medicinal Products): A set of international ISO standards aimed at providing a globally consistent way to identify and exchange information on medicinal products.
• Industry Cloud: A specialized cloud computing platform tailored to the specific needs, regulations, and best practices of a particular industry, such as life sciences.
• Swivel-Chair Process: A term used to describe inefficient manual data transfer between disconnected systems, often involving re-keying information, leading to errors and delays.

Examples/Case Studies:

• The video uses the example of changing a piece of manufacturing equipment to illustrate the complex regulatory impact assessment process, including identifying impacted licenses and local market requirements.
• It cites real-world examples of larger organizations evaluating tens of thousands of change requests annually and approving upwards of 15,000 changes, highlighting the sheer volume and complexity involved.
• Another example mentioned is a single product potentially undergoing over 200 changes in a given year, underscoring the continuous nature of change management in the industry.